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United States · US · US:80725-630_120a3a37-e84a-406b-94f8-243897706dc6

TABLOID

Orange BookUNIISPLATC L01BB03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeL01BB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8072563025
    1 BOTTLE in 1 CARTON (80725-630-25) / 25 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
FTK8U1GZNX
THIOGUANINE
RxCUI 10485
Orange Book
N012429
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FTK8U1GZNX",
    "rxcui": "10485",
    "inchikey": "VOXBZHOHGGBLCQ-UHFFFAOYSA-N",
    "display_name": "THIOGUANINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "44b0c461-47fb-4106-ba11-6ed85530235c": {
      "match": "brand_token",
      "title": "TABLOID (THIOGUANINE) TABLET [WAYLIS THERAPEUTICS LLC]",
      "spl_version": "3",
      "published_date": "2025-01-10"
    }
  },
  "productid": "80725-630_120a3a37-e84a-406b-94f8-243897706dc6",
  "productndc": "80725-630",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "012429",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THIOGUANINE",
  "proprietary_name": "TABLOID",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA012429",
  "marketing_category": "NDA",
  "nonproprietary_name": "thioguanine",
  "start_marketing_date": "20230515",
  "active_numerator_strength": "40"
}

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